Spirit® Hydrocolloid Adhesive Sheath 35305Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741070969), received between Apr 9, 2018 and Mar 15, 2022 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER ADHESIVE WAS HAVING ISSUES LIKE GETTING OFF THE USER SKIN WITH SOAP AND WATER/ ALCOHOL. IT WAS STATED THAT THE GLUE DID NOT COME OFF WITH SOAP AND WATER AND WHEN THE PATIENT USES ALCOHOL IT JUST BALLS UP AND STICKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776210 ↗
• InjuryJan 14, 2022Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED AN OPEN BLEEDING SORE DOWN THE SIDE OF PENIS, AND THAT WAS INFECTED. PATIENT HAD BEEN WEARING DIAPER. IT WAS NOTED THAT THE PATIENT HAD BEEN USING PRODUCTS FOR MORE THAN 90 DAYS. PER ADDITIONAL INFORMATION RECEIVED ON 05JAN2022, IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED AN OPEN BLEEDING SORE DOWN THE SIDE OF THE PENIS. STATED THAT THE PATIENT SAW A DOCTOR AND A PRESCRIPTION WAS GIVEN. PER CUSTOMER VIA PHONE ON (B)(6) 2022, CUSTOMER STATED THAT CUSTOMER RETURNED THE SAMPLE AND THE SORE WAS AT THE TIP OF THE PENIS AND CUSTOMER WAS PRESCRIBED AN ANTIBIOTIC CREAM BY THE DOCTOR TO TREAT THE SORE. CUSTOMER WOULD CALL LIBERATOR FOR OBTAINING A DIFFERENT SIZE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pressure Sore/Ulcer; Unspecified Infection

  MAUDE report 13258619 ↗
• MalfunctionOct 5, 2021Inadequate or Insufficient Training; Inadequate or Insufficient Training

  IT WAS REPORTED THAT SOME OF THE MALE EXTERNAL CATHETERS WERE NOT STAYING ON AND CAME RIGHT OFF. THE PATIENT WANTED TO KNOW HOW TO USE THE CATHETER. THE REPRESENTATIVE ADVISED ON HOW TO PUT THE CATHETER ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576612 ↗
• MalfunctionMay 18, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER ALMOST TORE PATIENT'S FORESKIN OFF OF MANHOOD. NO MEDICAL INTERVENTION REPORTED. PER REPORTED ISSUE ON (B)(6) 2021, THE MALE EXTERNAL CATHETER HAD TOO MUCH ADHESIVE AND RIPPED THE SKIN.

  Patient problems: Skin Tears

  MAUDE report 11841892 ↗
• MalfunctionDec 5, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE IRRITATING THE PATIENT'S SKIN AND HURTS WHILE REMOVING THE MALE EXTERNAL CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Irritation; Pain

  MAUDE report 10951085 ↗
• MalfunctionOct 21, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT ONE OF THE PACKAGE WAS SEALED, BUT IT WAS EMPTY, THERE WAS NO CATHETER OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 10713493 ↗
• InjuryJul 1, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED IRRITATION AND INFECTION FROM THE LAST ORDER. IT WAS NOTED THAT THE PATIENT WENT TO THE DOCTOR AND WAS TREATED.

  Patient problems: Skin Irritation; Unspecified Infection

  MAUDE report 10219779 ↗
• MalfunctionMay 27, 2020Nonstandard Device; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS TOO DIFFICULT AND PAINFUL TO REMOVE.

  Patient problems: Pain

  MAUDE report 10091524 ↗
• MalfunctionOct 7, 2019Nonstandard Device; Product Quality Problem; Structural Problem; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE TOO STICKY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9163693 ↗
• MalfunctionNov 30, 2018Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD TROUBLE REMOVING THE SPIRIT MALE EXTERNAL CATHETER. THE PATIENT PROCEEDED TO USE ALCOHOL TO REMOVE THE MEC. UPON REAPPLICATION OF THE CATHETER THE PATIENT STATED THAT THE CATHETER ONLY REMAINED IN PLACE FOR TWO HOURS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8120961 ↗
• MalfunctionSep 20, 2018Nonstandard Device; Appropriate Device Problem Term/Code Not Available; Nonstandard Device

  IT WAS REPORTED THAT THE COMPLAINANT HAD TO USE ISOPROPYL ALCOHOL TO REMOVE THE MALE EXTERNAL CATHETER. THE COMPLAINANT REPORTED THAT HE ATTEMPTED TO USE THE RECOMMENDED WARM WATER AND WASH CLOTH BUT IT CAUSED HIM PAIN AND DID NOT WORK TO REMOVE THE ADHESIVE.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 7894808 ↗
• MalfunctionApr 9, 2018Nonstandard Device; Nonstandard Device; Difficult to Remove; Sticking

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS "STICKING TOO GOOD" AND RESULTED IN DIFFICULTY GETTING THE CATHETER OFF.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7406704 ↗